Clinical Trials

As the Juravinski Cancer Centre (JCC) is affiliated with McMaster University, JCC oncologists are involved in research through the conduct of clinical trials. Through participation in a clinical trial, patients and their families have the opportunity to access the newest ideas about controlling cancer and are able to partner with researchers in contributing to progress in cancer research. The Centre participates in trials for all types and stage of cancer and includes trials of cancer diagnosis, treatment, supportive care and prevention.

The Clinical Trials Department at JCC is one of the largest in Canada. In 2008, 800 patients were recruited to JCC clinical trials and currently, there are approximately 100 active trials open to recruitment. The Department partners with the National Cancer Institute of Canada Clinical Trials Group, the Radiation Therapy Oncology Group and also participates in trials sponsored by the Pediatric Oncology Group of Ontario and the Ontario Clinical Oncology Group. As part of a unique consortium , we collaborate with several other cancer centres in Ontario to conduct studies of drugs in the early stage of clinical development.

All clinical trials that are presently open to enrollment are listed on the Ontario Institute for Cancer Research web site: Welcome to Ontario Cancer Trials.

For more information, please view our virtual tour and select the Clinical Trials chapter.  Click here to play the video.

Background to a Clinical Trial

To accomplish its goals, a clinical trial must follow a strict research plan or protocol. This carefully outlines the trial design, the characteristics of the patients that can be entered and details how the treatment must be given. It outlines anticipated side effects, tests required to be done and the information to be collected at each visit. Independent committees oversee issues such as ethics or clinical trial safety. External monitors visit the cancer centre to verify the smooth running of the trials.

Some clinical trials may test the usefulness of new treatments. Other trials look at ways of preventing cancer, detecting it early or improving the quality of life in cancer patients. The information obtained from this research contributes to our knowledge of cancer, results in progress in the treatment and provides direction for future research.

Once a treatment or procedure has proven to be effective, the research findings are published and the new treatment is submitted for approval. Eventually, it may become the new standard for that particular type of cancer. All the present standard treatments we use have come about from patients in the past agreeing to participate in clinical trials

The Different Types of Clinical Trials

There are three phases of clinical trials in cancer research. A brief overview of each phase of clinical trial is provided below. Further details can be obtained from Clinical Trials - A guide for People With Cancer, published by the Canadian Cancer Society.

Phase I trials look at how safe a treatment is and what the best dose of a medication is. Phase I trials are riskier than later trial phases because this is the first time the new drug or therapy is being tested on humans. For this reason, Phase I trials usually involve only a small number of people with cancer, about 15 to 30 people. The first patients will receive a low dose of the treatment and are watched very closely. If there are no side effects or if the side effects are minor, then the next group of patients will receive a higher dose. This continues until the investigators find the dose that works best with an acceptable level of side effects.

Phase II trials test how well new drugs or therapies work, once they have been proven to be reasonably safe in Phase I. Usually, a small group of people (fewer than100) get the same treatment in this phase of a clinical trial. The goals of these trials are to determine how effective the treatment was for the people on the trial and to show which types of cancer it might be used to treat.

Phase III trials involve large groups of people (hundreds or thousands). In Phase III trials, researchers compare treatments. They compare new treatments with the standard treatment, which is the best cancer treatment already in use. This means that everyone in the trial gets treatment. Researchers also gather more information about side effects that the new treatment may cause. Sometimes phase III trials are used to find out whether the new treatment is as effective as the standard treatment, but causes fewer side effects.

In addition to the trials described above, supportive care, prevention and screening trials are also carried out at JCC

Considering Entering a Clinical Trial

Ideally every patient seen at the JCC should be offered the opportunity to enter a clinical trial. In practice, some patients are not eligible. Research on human beings is highly regulated and there are consequences for researchers who don't follow the rules.

The two most usual times to consider a trial are after a new diagnosis of cancer or due to a change in condition such as recurrence or progression of cancer. Your oncologist will be aware of the treatments available for your situation and, while planning care, one of the options may be a clinical trial. Due to the heightened emotions associated with a new visit or a set back due to progression of cancer, discussion of a research project may not at first seem the top priority.

Those interested in obtaining more information about clinical trials should always ask. If a trial is available, you will meet with a clinical trials staff member. The trial will be explained to you including, the treatment plan, the risks and benefits and alternative therapies that may be available. You will be encouraged to think about your options and discuss them with your family, friends or your other physicians.

If you have decided to take part, you will be asked to sign a consent form. Additional blood tests or x-rays may need to be done to make sure you meet all of the criteria to enter the trial. Once the test results are known and you are eligible, the trial can begin.

Your progress will be followed closely by the clinical trials team and more tests or visits may be needed than if you were not in a trial. If you change your mind, You can stop the trial right away. Your oncologist will then talk about the other treatments available.

What are the Pros and Cons of Entering a Clinical Trial?

Pros

• By looking at all the treatment choices available to you, including clinical trials, you are taking an active role in a decision that affects your life.
• Clinical trials offer high quality care regardless of the treatment you are allocated to. In a randomized trial, patients not getting the new treatment will get the best current standard treatment. This may be as good as or better than the new treatment.
• If a new treatment is proven to be effective and you are taking it, you would be amongst the first to benefit.
• Entering a clinical trial gives you the chance to help others improve treatment options.
• The potential for closer monitoring involving more visits to the Cancer Centre.

Cons

• New treatments or procedures are not always better and may have consequences that are not expected and are worse than those of the standard treatment.
• If you get the standard treatment instead of the new treatment, it may not be as effective as the new treatment.
• An increased number of tests and visits to the clinic (some patients may not regard this a negative aspect).

Only you can decide about whether to take part in a clinical trial after gathering information on the options, risks and benefits of the treatments offered. Talking with members of your health care team will help you make a better decision.